Scientist II, Analytical Development and Clinical QC

Alexion•New Haven, CT

7d•Hybrid

About The Position

As a Scientist II, Analytical Development and Clinical QC at Alexion, you'll be at the forefront of our Late-Stage Analytical team! This pivotal role demands analytical expertise and a proven track record in managing analytical development projects throughout the CMC lifecycle. You'll prioritize multiple projects, collaborating closely with PDCS teams, Regulatory, QA, and external QC laboratories. Develop and implement late-stage analytical strategies, including method transfer, validation, and verification, while authoring regulatory filings with a keen understanding of country-specific requirements. As the analytical functional lead for clinical CMC programs, you'll drive end-to-end analytical activities from Phase 3 through commercialization.

Requirements

Advanced degree (PhD or MSc) in Biochemistry, Analytical Chemistry, Molecular Biology, Pharmaceutical Sciences, or related field
4+ years of progressive experience in biologics analytical development across clinical and commercial stages.
Proven hands-on strategic and technical expertise with monoclonal antibodies, bispecific, fusion proteins.
Technical expertise in chromatography (e.g., SEC, RP, IEX), capillary electrophoresis (CE-SDS, cIEF), spectroscopy (UV/Vis, fluorescence, CD), bioassays (binding, potency), and residuals/impurities testing (HCP, DNA, residual Protein A)
Compendia method experience with a focus on USP, EP and JP compliance
Strong written and verbal skills for clear reports, regulatory submissions, and presentations to technical and non-technical collaborators
Demonstrated success in method development, qualification/validation (per ICH Q2), transfer to QC/CMOs, and continued verification for commercial control strategies.
Strong command of ICH (Q5E, Q6B, Q8–Q12), USP/EP, FDA/EMA expectations for biologics, GMP/GLP compliance, and authoring/reviewing CTD Module 3, IND/IMPD, BLA/MAA analytical sections and responses to agency queries.
Proficiency with GxP compliant documentation, ALCOA+ data integrity principles, OOS/OOT handling, deviation/CAPA management, and audit readiness
Ability to define critical quality attributes (CQAs build specifications, and implement commercial control strategies aligned with Quality by Design (QbD)

Nice To Haves

Background in analytical method development and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as statistical data analysis and relevant tools
Leading all aspects of CDMO/CRO analytical activities including routine testing oversight, troubleshooting and investigations and method qualification, validation, and transfer.
Experience in country specific compendia requirements and knowledge of CHP
Experience in ICH stability programs (Q1), shelf-life modeling and projections and related statistical approaches
Experience in extended characterization and comparability including forced degradation studies for process comparability and life cycle management.
Digital laboratory systems and automation: Familiarity with LIMS, ELN, Chromatography Data Systems, data visualization, and automation/robotics in analytical workflows
Expertise with AI tools and statistical software, for example jmp

Responsibilities

Lead all aspects of analytical method validations, transfers, and compendia method verifications across all stages of clinical development and method life-cycle stages.
Serve as the analytical lead for CMC programs, focusing on late-stage programs with rigorous cross-functional collaboration.
Develop and implement an analytical end-to-end strategy for key late-stage biologics programs, including control strategy, lifecycle management, and QC testing oversight.
Lead all aspects of analytical QC testing, troubleshooting issues, and conduct data analysis to ensure program health and identify potential risks.
Author regulatory submissions for clinical and commercial markets, addressing health authority queries and requests for information.